Registry for using a new PET scan to track recurrent prostate cancer

PSMA-PET Registry for Recurrent Prostate Cancer

This study is testing a new type of PET scan to see if it can better find recurring prostate cancer in men who have had treatment before and have rising PSA levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3070 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Drugs / interventions: radiation
• Locations: 6 sites (Hamilton, Ontario and 5 other locations)
• Trial ID: NCT03718260 on ClinicalTrials.gov

What this trial studies

This registry aims to utilize a new Positron Emission Tomography (PET) tracer, [18F]-DCFPyL, across various centers in Ontario to enhance the identification of recurrent prostate cancer in men who have previously undergone treatment. By focusing on patients with rising Prostate Specific Antigen (PSA) levels or node-positive disease, the study seeks to determine if this advanced imaging technique can reveal areas of cancer recurrence that traditional imaging methods may miss. The results from the PET scans will inform treatment decisions, with participating physicians reporting on how the findings influence patient management. The study will track subsequent interventions through linkage to provincial registries.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older who have had prior curative treatment for prostate cancer and show signs of suspected recurrence.

Not a fit: Patients without a history of prostate cancer treatment or those not showing signs of recurrence may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate detection of recurrent prostate cancer and personalized treatment plans for affected patients.

How similar studies have performed: Other studies utilizing advanced PET imaging techniques have shown promise in improving cancer detection, suggesting potential success for this novel approach.

Eligibility criteria

Phase 2

Inclusion Criteria:

1. Written informed consent obtained
2. Male, Age ≥ 18 years
3. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer. Unless PET/CT requested as part of Cohort 7.
4. Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):

   1. High risk disease at the time of radical prostatectomy characterized by pathologically involved node(s) or persistently detectable PSA (\>0.1ng/ml) within 3 months post-surgery
   2. Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:

   i. Following primary radical prostatectomy, BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured at \>0.1 ng/ml

   ii. Following primary radiotherapy for localized disease, BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured greater than the nadir PSA + 2.0 ng/ml
5. Patient scenario falls into one of the 7 pre-defined cohorts. When patient scenario falls outside cohorts 1-6 participation in the Registry must be approved through the established CCO adjudication process for Cohort 7.
6. Karnofsky performance status 70 or better (ECOG 0, 1).
7. If PSA \>10 mg/mL, conventional imaging consisting of bone scan and abdo-pelvic CT scan within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified).

Exclusion Criteria:

1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
2. Prior PSMA PET scan within 6 months of enrollment.
3. Patient cannot lie still for at least 60 minutes or comply with imaging.
4. Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.

Where this trial is running

Hamilton, Ontario and 5 other locations

• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
• London Health Sciences Centre — London, Ontario, Canada (Recruiting)
• The Ottawa Hospital, General Campus — Ottawa, Ontario, Canada (Recruiting)
• Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (Recruiting)
• Toronto Sunnybrook Cancer Centre — Toronto, Ontario, Canada (Recruiting)
• Princess Margaret Cancer Centre, University Health Network — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Glenn Bauman, MD, FRCPC — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Study coordinator: Catherine Hildebrand, PhD, Project Coordinator

Conditions Recurrent Prostate Cancer; Prostate Cancer; Biochemical Failure; Node positive; PSMA-PET; [18F]DCFPyL PET/CT imaging; Radical Prostatectomy; Radiation Therapy